Biosimilars 2014

Topics

• Guideline revisions - status quo
• Clinical testing: immunogenicity & bioequivalence
• Safety testing in the pre-authorisation phase
• Worldwide development programmes - US FDA approach, EU approach
• CMC data - comparability data, reference drugs

Aims and objectives

We would like to give you a thorough update on the new challenges and opportunities arising in connection with the revision of the overarching biosimilar guideline and the upcoming further guidelines/revisions. We would like to discuss with you the clinical topics, as well as the quality requirements and vigilance aspects. After having completed the seminar you will be familiar with the current regulatory requirements and have a good insight into the European, the US and worldwide biosimilars development programmes, recognising that each region has its own challenges and opportunities. May we invite you to a firsthand update?

Ihre Referenten